MAUDE Adverse Event Report: DATASCOPE CORP. TRANS-RAY PLUS 7.5FR 40CC IAB WITH ACCESSORIES; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0608
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that blood had entered the sleeve.There was no patient harm or injury reported.
Event or Problem Description
It was reported that blood had entered the sleeve.There was no patient harm or injury reported.
Additional Manufacturer Narrative
Updated fields b4 d9 d10 g3 g6 h2 h3 h6 type of investigation findings conclusion h11.The iab was returned with the membrane completely unfolded and blood on the exterior of the catheter and within the stat gard sleeve the extender tubing was also returned no blood was observed inside the iab catheter.An underwater leak test of the stat gard seal balloon catheter yfitting extracorporeal and extender tubing was performed and no leaks were detected.The reported event cannot be confirmed by the evaluation blood may also enter the stat gard sleeve when the sheath seal is moved back and forth this is the intention so blood does not spray over the user and patient note per instructions for use if blood is seen passing the sheath seal following insertion through a sheath disengage sheath seal from hemostasis valve a lot history record review was completed for the reported product no nonconformances were found that are considered to be related to the event the failure mode is addressed in the risk file and is operating within its risk profile the ifu addresses the reported failure the device meets all product specifications there were no ncmrs identified which could cause or contribute to the reported failure the investigation does not indicate that the device was inadvertently released as nonconforming or an adulterated product or was a counterfeit the complaint history review did not identify an adverse trend increase in number of complaints over past three 3 months based on the rational provided above no escalation to the capa process is required.
Event or Problem Description
N/a.
Event or Problem Description
It was reported that blood had entered in the sleeve of intra aortic balloon (iab).There was no patient harm or injury reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: b5, e1 (event site name).Due to character limitation in block e1: event site name: (b)(6) hospital.

• Brand Name: TRANS-RAY PLUS 7.5FR 40CC IAB WITH ACCESSORIES
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 24321361
• Report Number: 2248146-2026-0000685
• Device Sequence Number: 9931088
• Product Code: DSP
• UDI-Device Identifier: 10607567111728
• UDI-Public: (01)10607567111728(17)271023(10)3000426639(11)241023
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0608
• Device Catalogue Number: 0684-00-0608
• Device Lot Number: 3000426639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/16/2026; 04/16/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/18/2026; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IABP.; UNKNOWN.
• Patient Sex: Unknown